Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota

NCT04086173 | Unknown

• 1 other identifier: 00000
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour

Conditions

Obesity; Insulin Resistance; Microbial Colonization

Outcome Measures

Primary Outcomes (8)

• Changes in fat mass in patients with obesity

  Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

  16 weeks

• Changes in fat percentage in patients with obesity

  Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

  16 weeks

• Changes in body mass index in patients with obesity

  Evaluate changes in body mass index after probiotics treatment in patients with obesity. Calculated with the weight in kilograms divided by the square of the height in meters

  16 weeks

• Changes in weight in patients with obesity

  Evaluate changes in weight kilograms after probiotics treatment in patients with obesity

  16 weeks

• Changes in lean body mass in patients with obesity

  Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

  16 weeks

• Changes in Insulin resistance indexes

  Modification in HOMA index after probiotics treatment in patients with obesity

  16 weeks

• Changes in Insulin sensitivity indexes

  Modification in insulin sensitivity index after probiotics treatment in patients with obesity

  16 weeks

• Changes in Quicki insulin sensitivity index

  Modification in Quicki index after probiotics treatment in patients with obesity

  16 weeks

Secondary Outcomes (10)

• Changes in glucose tolerance test

  16 weeks

• Changes in glycated haemoglobin

  16 weeks

• Changes in triglycerides

  16 weeks

• Changes in total cholesterol

  16 weeks

• Changes in HDL cholesterol

  16 weeks

Other Outcomes (3)

• Changes in microRNAs

  16 weeks

• Compare threshold for basic tastes

  16 weeks

• Changes in intestinal microbiota

  16 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of probiotics for 16 weeks. Probiotics (LACTIPAN®) include 2.5 billion CFU of 6 different strains of live microorganisms, such as Lactobacillus acidophilus (1.0 x 109 CFU), Lactobacillus casei (1.0 x 109 CFU), Lactobacillus rhamnosus (4.4 x 108 CFU), Lactobacillus plantarum (1.76 x 108 CFU), Bifidobacterium infantis (2.76 x 107 CFU), Streptococcus thermophilus (6.66 x 105 CFU) and 50 mg of oligofructose enriched inulin.

Dietary Supplement: Probiotics

Control group

PLACEBO COMPARATOR

Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of placebo for 16 weeks. Placebo presentation will have the same aspect as those of the probiotic treatment.

Other: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics will be administered at night and will consist of 4 capsules

Study group

Placebo OTHER

Placebo

Control group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with grade II y III obesity (IMC \> or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
• Patients who signed informed consent.

You may not qualify if:

• Diabetes mellitus 2
• Secondary causes of obesity (hypothyroidism, Cushing syndrome).
• Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
• Patients who received broad-spectrum antibiotics during the 4 previous weeks.
• Ingestion of products that contain probiotics.
• Relevant changes in diet habits during the 4 previous weeks
• Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C. difficile infection).

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead
• Italmex Pharma: collaborator
• Medix Farma: collaborator
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, Mexico

RECRUITING

Related Publications (5)

• Banegas JR, Lopez-Garcia E, Gutierrez-Fisac JL, Guallar-Castillon P, Rodriguez-Artalejo F. A simple estimate of mortality attributable to excess weight in the European Union. Eur J Clin Nutr. 2003 Feb;57(2):201-8. doi: 10.1038/sj.ejcn.1601538.

  PMID: 12571650 BACKGROUND

• Neish AS. Microbes in gastrointestinal health and disease. Gastroenterology. 2009 Jan;136(1):65-80. doi: 10.1053/j.gastro.2008.10.080. Epub 2008 Nov 19.

  PMID: 19026645 BACKGROUND

• Hooper LV, Wong MH, Thelin A, Hansson L, Falk PG, Gordon JI. Molecular analysis of commensal host-microbial relationships in the intestine. Science. 2001 Feb 2;291(5505):881-4. doi: 10.1126/science.291.5505.881.

  PMID: 11157169 BACKGROUND

• Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155. doi: 10.1186/s12916-016-0698-z.

  PMID: 27724956 BACKGROUND

• Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.

  PMID: 17183309 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance; Communicable Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nayely Garibay-Nieto, MSc

  Hospital General de Mexico Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayely Garibay, MSc

CONTACT

+525546037000; gngaribay@hotmail.com

Alejandro Velasco, MSc

CONTACT

+525541449172; jano_vm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the participant nor the Care provider administrating treatment will know the type of treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Child and Adolescent Obesity Clinic

Model Details: Double-blinded randomized placebo-controlled clinical assay

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: September 11, 2019
• Study Start: March 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: July 31, 2020
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)